NA 04.005.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982085887), received between Oct 24, 2018 and Feb 4, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO PAIN. THERE WAS NO MALFUNCTION IN HARDWARE NOTED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13451157 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 10 TI CANNULATED TIBIAL NAIL-EX/315-SILE. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12199728 ↗
• InjuryNov 20, 2020Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AROUND 9PM TO REPOSITION THE EXPERT HAN NAIL, EXPERT END CAP, SPIRAL BLADE, AND THREE (3) LOCKING SCREWS. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2020 IN THE AFTERNOON. THE SURGEON ORIGINALLY PLACED THE EXPERT HAN NAIL BUT DIAGNOSTIC IMAGING SHOWED EVIDENCE THAT THE EXPERT HAN NAIL REMAINED EXTRAMEDULLARY IN THE MID-DISTAL THIRD OF THE TIBIA. THIS REQUIRED REVISION SURGERY TO CARRY OUT REPOSITIONING OF THE IMPLANTS. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) LOCKSCR 5 L30 F/NAILS TAN LIGHT GREEN. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10876957 ↗
• InjuryNov 20, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AROUND 9PM TO REPOSITION THE EXPERT HAN NAIL, EXPERT END CAP, SPIRAL BLADE, AND THREE (3) LOCKING SCREWS. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2020 IN THE AFTERNOON. THE SURGEON ORIGINALLY PLACED THE EXPERT HAN NAIL BUT DIAGNOSTIC IMAGING SHOWED EVIDENCE THAT THE EXPERT HAN NAIL REMAINED EXTRAMEDULLARY IN THE MID-DISTAL THIRD OF THE TIBIA. THIS REQUIRED REVISION SURGERY TO CARRY OUT REPOSITIONING OF THE IMPLANTS. THERE WAS PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10876416 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANTS DUE TO HIP ARTHRITIS AND DECREASED RANGE OF MOTION (ROM). THE PATIENT WAS THEN REVISED WITH A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 10465590 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. THE DEVICES REMOVED WERE ONE (1) HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0MM TITANIUM LOCKING SCREW, ONE (1) TITANIUM END CAP, ONE (1) TITANIUM LOCKING SCREW 50MM, AND TWO (2) TITANIUM LOCKING SCREWS 30MM. THE ORIGINAL IMPLANT FOR THE DEVICES IS AUGUST 24, 2018. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: VIVIGEN FORMABLE BIOLOGIC TISSUE MATRIX (PRODUCT# BL-1600.002, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 7 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002228 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. THE DEVICES REMOVED WERE ONE (1) HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0MM TITANIUM LOCKING SCREW, ONE (1) TITANIUM END CAP, ONE (1) TITANIUM LOCKING SCREW 50MM, AND TWO (2) TITANIUM LOCKING SCREWS 30MM. THE ORIGINAL IMPLANT FOR THE DEVICES IS (B)(6) 2018. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: VIVIGEN FORMABLE BIOLOGIC TISSUE MATRIX (PRODUCT# BL-1600.002, LOT UNKNOWN, QUANTITY 1) THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM FOR IM NAILS THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 6 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002183 ↗